FDA OKs fast-action erectile dysfunction drug Stendra

Vivus and marketing partner Auxilium Pharmaceuticals will no doubt be popping corks after US regulators cleared a faster-acting version of their erectile dysfunction drug Stendra (avanafil), potentially giving it a stronger competitive edge against market giants Viagra (sildenafil) and Cialis (tadalafil).

The US Food and Drug Administration has approved a supplementary New Drug Application for Stendra supporting its use 15 minutes before the onset of sexual activity, allowing for more flexibility and spontaneity than with Viagra, which needs to be taken one-two hours before while Cialis is taken once daily.

The drug originally got the US regulatory nod in 2012 for use 30 minutes before an erection is required, and Adrian Adams, Auxilium’s chief executive officer, said the new label expansion will help position it “as an exciting 'on demand' ED treatment [that] assists with the very important aspect of spontaneity for men and their partners in real world use”.

Avanafil, a member of the phosphodiesterase type 5 (PDE5) inhibitor class of drugs, is also approved in Europe for the treatment of ED, where it is marketed as Spedra.